Polyisoprene Extra Large Condom— 510(k) K232470

Name: FDA 510(k) clearance K232470
Creator: U.S. Food and Drug Administration
Published: 2024-05-09

Substantially Equivalent

Suretex Limited

FDA 510(k) clearance K232470 for Polyisoprene Extra Large Condom, Substantially Equivalent on 2024-05-09. Applicant: Suretex Limited. Device class: 2.

Clearance details

Applicant: Suretex Limited
Product code: Code MOL
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2023-08-16
Decision date: 2024-05-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Suratthani, TH

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.